QA and Auditing Lead

Role Overview

Seeking a proactive Quality Assurance and Auditing Lead for a rapidly expanding nutraceutical company in the U.S. This position suits someone drawn to startup environments who embraces autonomy, ownership, and has a passion for problem-solving through deep investigation and research. The company supports a balance between work and personal life, offering strong leadership and the chance to profoundly influence and shape quality systems effectively.

Key Responsibilities

• Manage and keep the quality management system up to date, ensuring regulatory compliance and effectiveness.
• Organize and conduct internal audits; lead quality investigations from start to finish, acting as the project owner or manager.
• Provide training to internal personnel and suppliers on quality systems, SOPs, and relevant processes.
• Handle supplier and manufacturing site oversight, including onboarding audits and continuous quality monitoring.
• Travel frequently to manufacturing facilities to conduct audits and facilitate technical site transfers.
• Supervise raw material receiving, qualification, and release procedures.
• Review and approve Certificates of Analysis, batch records, and all essential documentation before batch approval.
• Monitor, analyze, and report on customer complaints related to product quality and track quality metrics.
• Lead product registration initiatives and assist with regulatory-required labeling updates.
• Ensure precise documentation, maintaining integrity and completeness across all quality activities.
• Communicate efficiently with cross-functional teams and ensure quality actions are completed.
• Create and update Quality dashboards and reports tracking key indicators to promote continuous quality system enhancement.
• Approve product labels and manage registrations and certifications for Mitra9 products where applicable.
• Conduct GMP training sessions and review product claims for compliance.
• Drive the definition and tracking of monthly Quality KPIs (including deviations, CAPA, supplier performance, complaints, batch release timeframes, audits) and lead monthly Quality performance reviews presented to leadership.

Qualifications and Experience

• Minimum 7 years in quality assurance roles.
• At least 3 years auditing companies and overseeing quality management systems.
• Minimum 2 years of direct experience with batch record review and release processes.
• Experience in the Consumer Packaged Goods sector, preferably within the nutraceutical industry.
• Ability to thrive amid rapidly evolving priorities in a dynamic environment.
• Strong investigative skills to support decision-making with research and analysis.
• Keen interest in regulatory compliance and adaptability to interstate laws, labeling, and regulatory modifications.
• Detail-oriented approach with enthusiasm for research and accuracy in execution.
• Excellent communication skills with the ability to collaborate well across multiple departments.
• Collaborative team player demonstrating ownership and follow-through on projects.
• Proven capability to develop and maintain quality performance metrics and report effectively to executive leadership.
• Proactive, accountable, and able to handle urgent matters efficiently.
• Availability to travel frequently based on company requirements.

Preferred Attributes

• Exceptional attention to detail and a committed quality mindset.
• Independent project ownership combined with leadership collaboration skills.
• Organized, adaptable, and motivated to achieve measurable results.
• Preference for developing and enhancing systems rather than merely sustaining existing processes.